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The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is:
• What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flotufolastat F-18 Injection | Drug | All patients will receive one injection of Flotufolastat F-18 Injection, a PET radiopharmaceutical selective for PSMA. For the injection, subjects will receive a target dose of 8 mCi (296 MBq) ± 20% IV as a bolus injection. Flotufolastat F-18 Injection will be followed by a 10 ml saline flush. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR) | Correct Detection Rate (CDR) at the individual level of Flotufolastat F-18 Injection PET imaging in prostate cancer subjects with BCR | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate other diagnostic performance parameters of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with BCR | Positive predictive value (PPV) of Flotufolastat F-18 Injection PET imaging at the individual level in prostate cancer subjects with BCR. PPV and CDR of Flotufolastat F-18 Injection PET imaging in the prostate bed, pelvic lymph nodes, and three other regions in Chinese prostate cancer subjects with BCR. |
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Inclusion Criteria:
1. Fully understand the study and voluntarily sign the informed consent form. 2. Male, aged ≥18 years. 3. Has previously received one or more of the following treatments:
Radical prostatectomy (RP);
RP with adjuvant radiotherapy (RT);
RP with adjuvant androgen deprivation therapy (ADT);
Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound [HIFU]).
4. Clinically suspected BCR, serum PSA levels should meet at least one of the followings:
5. If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation.
6. Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruimin Wang, Doctor | Contact | 010-66938008 | wrm@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100089 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 90 days |
| To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR | Individual-level PPV and CDR of Flotufolastat F-18 Injection PET imaging in subjects whose baseline conventional imaging is negative. Individual-level PPV and CDR of Flotufolastat F-18 Injection PET imaging at different PSA levels. | 90 days |
| To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers. | Kappa values for inter-reader and intra-reader agreement in the interpretation of the same Flotufolastat F-18 Injection PET imaging by different independent blinded readers and by the same reader at different times. | 90 days |
| To evaluate the safety of Flotufolastat F-18 Injection . | The types, severity, frequency, and outcomes of adverse events/serious adverse events reported during the study period. | 3 days |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |